title: The diaphragm and lubricant gel for prevention of cervical sexually transmitted infections: results of a randomized controlled trial.
abstract: BACKGROUND
  We evaluated the effectiveness of the Ortho All-Flex Diaphragm, lubricant gel (Replens) and condoms compared to condoms alone on the incidence of chlamydial and gonococcal infections in an open-label randomized controlled trial among women at risk of HIV/STI infections.
  
  
  METHODS
  We randomized 5045 sexually-active women at three sites in Southern Africa. Participants who tested positive for curable STIs were treated prior to enrollment as per local guidelines. Women were followed quarterly and tested for Chlamydia trachomatis (CT) or Neisseria gonorrhoeae (GC) infection by nucleic-acid amplification testing (Roche Amplicor) using first-catch urine specimens. STIs detected at follow-up visits were treated. We compared the incidence of first infection after randomization between study arms in both intent-to-treat (ITT) and per-protocol populations.
  
  
  RESULTS
  Baseline demographic, behavioral and clinical characteristics were balanced across study arms. Nearly 80% of participants were under 35 years of age. Median follow-up time was 21 months and the retention rate was over 93%. There were 471 first chlamydia infections, 247 in the intervention arm and 224 in the control arm with an overall incidence of 6.2/100 woman-years (wy) (relative hazard (RH) 1.11, 95% Confidence Interval (CI): 0.93-1.33; p = 0.25) and 192 first gonococcal infections, 95 in the intervention arm and 97 in the control arm with an overall incidence of 2.4/100wy (RH 0.98, 95%CI: 0.74-1.30; p = 0.90). Per protocol results indicated that when diaphragm adherence was defined as "always use" since the last visit, there was a significant reduction in the incidence of GC infection among women randomized to the intervention arm (RH 0.61, 95%CI: 0.41-0.91, P = 0.02).
  
  
  CONCLUSIONS
  There was no difference by study arm in the rate of acquisition of CT or GC. However, our per-protocol results suggest that consistent use of the diaphragm may reduce acquisition of GC.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00121459.
authors.affiliation: Medical Research Council, Durban, South Africa. ramjeeg@mrc.ac.za
authors.forename: Gita
authors.initials: G
authors.lastname: Ramjee
authors.forename: Ariane
authors.initials: A
authors.lastname: van der Straten
authors.forename: Tsungai
authors.initials: T
authors.lastname: Chipato
authors.forename: Guy
authors.initials: G
authors.lastname: de Bruyn
authors.forename: Kelly
authors.initials: K
authors.lastname: Blanchard
authors.forename: Stephen
authors.initials: S
authors.lastname: Shiboski
authors.forename: Helen
authors.initials: H
authors.lastname: Cheng
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Montgomery
authors.forename: Nancy
authors.initials: N
authors.lastname: Padian
mesh_terms: D000328:Adult; D002690:Chlamydia Infections / Q000517:prevention & control; D002692:Chlamydia trachomatis / Q000302:isolation & purification; D017280:Condoms; D003274:Contraceptive Devices, Female / Q000592:standards*; D004269:DNA, Bacterial / Q000652:urine; D005260:Female; D006069:Gonorrhea / Q000517:prevention & control; D006801:Humans; D015994:Incidence; D054327:Lubricants / Q000592:standards*; D008875:Middle Aged; D009344:Neisseria gonorrhoeae / Q000302:isolation & purification; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D013019:South Africa; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004269:DNA, Bacterial; D054327:Lubricants